A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 57
- 主要终点
- Annual Rate of Decline in Forced Vital Capacity (FVC)
研究概览
简要总结
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.
The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).
As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBF 1120 low qd
Low dose BIBF 1120 once daily
干预措施: BIBF 1120 (Drug)
BIBF 1120 low bid
Low dose BIBF 1120 twice daily
干预措施: BIBF 1120 (Drug)
BIBF 1120 medium bid
Intermediate dose BIBF 1120 twice daily
干预措施: BIBF 1120 (Drug)
BIBF 1120 high bid
High dose BIBF 1120 twice daily
干预措施: BIBF 1120 (Drug)
结局指标
主要结局
Annual Rate of Decline in Forced Vital Capacity (FVC)
时间窗: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.
次要结局
- Overall Survival(From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months)
- Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation(From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months)
- Progression-Free Survival(From first trial drug intake in 1199.35 to disease progression; up to 61.8 months)
- Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease(From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months)
- Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs(From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days)
- Incidence of Patients With at Least One Acute IPF Exacerbation Over Time(From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months)
- Time to First Acute IPF Exacerbation(From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months)